|POSITION DUTIES & RESPONSIBILITIES|
• Develop proposals for project improvement projects or new technology evaluations. Gather information from stakeholders to assess business needs. Construct business cases for proposed projects, present proposals to stakeholders, and help to secure funding for projects.
• Plan and manage approved projects. Identify work breakdown structures and required resources. Sequence deliverables and generate project schedules. Execute the project plan and hold team members accountable (including the incumbent). Provide regular status updates to stakeholders. Escalate as necessary when circumstances external to the project threaten the planned execution of the project.
• Thoroughly document results in a format which enables colleagues to reference and build upon the results. Generate reports and seek opportunities to present results so that client can realize the benefits from the work performed.
• Follow required cGMP workflows. When working on projects, the incumbent will follow applicable SOPs, initiate, execute, or support required change control activities, participate in or lead risk assessments, and support qualification, validation, and regulatory submission activities. The incumbent will support manufacturing deviation investigations or responses to regulatory authority observations as requested.
• Engage in professional development activities. The incumbent will attend technical or other professional training to expand upon and improve his or her knowledge base or skill sets. The incumbent is encouraged to develop external networks by attending conferences or participating in inter company groups to increase awareness about external developments and competencies.
• Provide technical support and expertise to production during processing. This involves monitoring of key campaign parameters (yield/ quality) and taking appropriate action where necessary. This involves making real time technical assessments and determining the path forward when deviations occur, documenting the investigation.
• Gives internal presentations and talks. Seeks guidance from support groups, department experts, where appropriate. Able to interpret, understand and apply data provided by support groups. Provides technical input (data and interpretation) for plant preparations; integrates observations.
• Implement process development and improvement in the areas of cost, quality and customer service
• Continuously review manufacturing processes on the KS MO site to determine the most cost effective supply strategy.
• Provide dynamic support to manufacturing operations on site and off site through process maintenance, troubleshooting, process development, providing technical and chemistry support as leading Chemist in technology transfers to other sites
• Analyze densitometer or spectrometer readings to measure density ratio of specific elements in sample. Computes percentage composition of sample by comparing intensity ratio with standard charts. Investigates deviations from standard, performing further examinations by other spectrographic and NIR and Raman procedures and methods to establish degree of conformance to standard. Records quantitative determination, procedure, and standard applied for each sample examined.